Evidence map›Paper›PMID 22388884›Full record

Trial reportJournal of gastroenterology2012

Lansoprazole for secondary prevention of gastric or duodenal ulcers associated with long-term non-steroidal anti-inflammatory drug (NSAID) therapy: results of a prospective, multicenter, double-blind, randomized, double-dummy, active-controlled trial.

Kentaro Sugano, Teiji Kontani, Shinichi Katsuo, Yoshinori Takei, Nobuhiro Sakaki, Kiyoshi Ashida, Yuji Mizokami, Masahiro Asaka, Shigeyuki Matsui, Tatsuya Kanto and 4 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of gastroenterology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05005910 (Efficacy of Vonoprazan Versus Intravenous Proton Pump Inhibitors for Prevention of Rebleeding in High Risk Peptic Ulcers Bleeding After Successful Endoscopic Hemostasis), which is not on this map. Cited by 20 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 5 pooled it
3.2field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05005910 early_phase1completednot on this mapstarted 2021, after this paper: background citation

Efficacy of Vonoprazan Versus Intravenous Proton Pump Inhibitors for Prevention of Rebleeding in High Risk Peptic Ulcers Bleeding After Successful Endoscopic Hemostasis

TypeinterventionalSponsorUayporn KaosombatwattanaRan2021 to 2022Enrolled194ConditionsPeptic Ulcer With HaemorrhageArmsVonoprazan, PPIs IV infusion
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 5 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Guideline
  2. Pooled it
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  5. Pooled it
  6. Trial
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  12. Article
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  15. Review
  16. Advantages and Disadvantages of Long-term Proton Pump Inhibitor Use.Journal of neurogastroenterology and motility · 2018
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 13 institutions in 1 country.

Kentaro SuganoDivision of Gastroenterology, Department of Medicine, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan. sugano@jichi.ac.jp
Teiji Kontani
Shinichi Katsuo
Yoshinori Takei
Nobuhiro Sakaki
Kiyoshi Ashida
Yuji Mizokami
Masahiro Asaka
Shigeyuki Matsui
Tatsuya Kanto
Satoshi Soen
Tsutomu Takeuchi
Hideyuki Hiraishi
Naoki Hiramatsu
Osaka University · JPDokkyo Medical University · JPHokkaido University · JPIzumi City General Hospital · JPJapanese Foundation For Cancer Research · JPJichi Medical University · JPKeio University · JPKindai University · JPKomatsu (Japan) · JPSaiseikai Nakatsu Hospital · JPThe Institute of Statistical Mathematics · JPUniversity of Fukui Hospital · JPUniversity of Tsukuba Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLow-dose lansoprazole has not been intensively evaluated for its efficacy in the prevention of recurrent gastric or duodenal ulcers in patients receiving long-term non-steroidal anti-inflammatory drug (NSAID) therapy for pain relief in such diseases as rheumatoid arthritis, osteoarthritis, and low back pain.

methodsThis multi-center, prospective, double-blind, randomized, active-controlled study involving 99 sites in Japan was designed to compare the efficacy of lansoprazole (15 mg daily) with gefarnate (50 mg twice daily). Patients with a history of gastric or duodenal ulcers who required long-term NSAID therapy were randomized to receive lansoprazole 15 mg daily (n = 185) or gefarnate 50 mg twice daily (n = 181) and followed up for 12 months or longer prospectively.

resultsThe cumulative incidence of gastric or duodenal ulcer at days 91, 181, and 361 from the start of the study was calculated by the Kaplan-Meier method as 3.3, 5.9, and 12.7%, respectively, in the lansoprazole group versus 18.7, 28.5, and 36.9%, respectively, in the gefarnate group. The risk for ulcer development was significantly (log-rank test, P < 0.0001) lower in the lansoprazole group than in the gefarnate group, with the hazard ratio being 0.2510 (95% CI 0.1400-0.4499). A long-term follow-up study showed an acceptable safety profile for low-dose lansoprazole therapy, with diarrhea as the most frequent adverse event.

conclusionLansoprazole was superior to gefarnate in reducing the risk of gastric or duodenal ulcer recurrence in patients with a definite history of gastric or duodenal ulcers who required long-term NSAID therapy.

Indexed as

2-PyridinylmethylsulfinylbenzimidazolesAgedAnti-Inflammatory Agents, Non-SteroidalAnti-Ulcer AgentsArthritisDouble-Blind MethodDuodenal UlcerFemaleGefarnateHumansKaplan-Meier EstimateLansoprazoleLow Back PainMaleMiddle AgedProspective Studies2-PyridinylmethylsulfinylbenzimidazolesAnti-Inflammatory Agents, Non-SteroidalAnti-Ulcer AgentsGefarnateLansoprazole

Identifiers

PMID22388884
PMCPMC3360874
OpenAlexW2047650023

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.